Last Updated: November 8, 2026

Details for New Drug Application (NDA): 087725

NDA 087725 describes UROVIST SODIUM 300, which is a drug marketed by Bayer Hlthcare and is included in one NDA. Additional details are available on the UROVIST SODIUM 300 profile page.

The generic ingredient in UROVIST SODIUM 300 is diatrizoate sodium. There is one drug master file entry for this compound. Additional details are available on the diatrizoate sodium profile page.

Summary for 087725

Tradename:	UROVIST SODIUM 300
Applicant:	Bayer Hlthcare
Ingredient:	diatrizoate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50%
Approval Date:	Sep 23, 1982	TE:		RLD:	No

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